TEL AVIV, Israel, Sept. 12, 2019 /PRNewswire/ -- Today,
Healthy.io, the global leader in turning the smartphone camera into
a clinical-grade medical device, announced it has received 510(k)
clearance from the U.S. Food and Drug Administration
(FDA) for its smartphone-based ACR test to be used in the
aid of diagnosing chronic kidney disease (CKD), which affects over
35 million Americans. This is the second FDA clearance the company
has received. The company also closed a $60 million Series C funding round led by Corner
Ventures with participation by Joy Capital and all previous
investors: Ansonia Holdings, Aleph, and Samsung NEXT.
The funding round will be used to accelerate Healthy.io's global
expansion and product development. Additionally, the company
announced that longtime leader in health care innovation, former
executive vice president of Aetna Gary
Loveman, Ph.D. will join its Board of Directors.
"The smartphone has the potential to be the great equalizer of
healthcare," said Yonatan Adiri,
founder and CEO of Healthy.io. "To unlock this potential, companies
must adhere to the highest clinical standards. Our second FDA
clearance and additional funding allows us to expand access to
critical tests and care beyond our first 100,000 patients in
Europe and Israel, making it a reality for millions of
Americans suffering from diabetes and hypertension, who are at risk
for chronic kidney disease."
The FDA clearance designates Healthy.io's smartphone-based ACR
test as substantially equivalent to lab-based testing and
authorizes the use of the test by healthcare professionals at any
point of care. It makes it possible for any pharmacy, urgent care
center, or health clinic to perform the test without investing in a
tabletop lab device. In addition, Healthy.io's solution allows
immediate electronic medical record (EMR) connectivity through the
automated smartphone scan.
Last year, the company received clearance for its at-home,
smartphone-based 10 parameter urinalysis test kit, called Dip.io,
that can be used in testing for UTIs or in prenatal care. Next, the
company plans to continue the approval process for its ACR test kit
for at-home use.
"Today's health system doesn't make it easy for patients to get
the care they need. Healthy.io is tackling this problem by meeting
patients where they are, on their smartphones, and turning
smartphone cameras into a clinical-grade medical device," said
Michael Eisenberg, general partner
at Aleph. "We are proud to support a company that can meet the
highest FDA standards, while creating products that make life
easier and more convenient for patients."
With the new funding, Healthy.io will continue its product
development. The company recently announced a partnership
with the NHS in addition to other retail pharmacies, placing
its Dip UTI test kits in hundreds of pharmacies, allowing women to
test and treat common UTIs, and announced a new pharmacy evaluation
with the National Health Service (NHS) in England.
In the U.S. Healthy.io has worked with Johns Hopkins University and Geisinger Health,
publishing strong results for its prenatal care and CKD testing
products. To advise its U.S. work, the company has added
Gary Loveman to its Board of
"Today, too many patients face barriers to care, leading to
missed appointments, undiagnosed conditions, and increased visits
to the emergency room or hospital. Healthy.io is establishing
itself as a leader in a new world of broader, decentralized access
to care without compromising on clinical quality," said Loveman.
"With this FDA clearance, Healthy.io adds a critical test to its
portfolio in the U.S., which can make ACR testing dramatically more
accessible and convenient, leading to a big difference in the
management of at-risk populations."
Loveman was previously the executive vice president of Aetna and
president of the health plan's Consumer Health and Services
business. In that role, he led the company's population health
management and consumer engagement strategies, including care
management, digital consumer health products, analytics, and data
science. Prior to joining Aetna in 2015, Loveman served as
Chairman, CEO, and President of Caesars Entertainment Corporation.
During his time at Caesars, Loveman chaired the Business
Roundtable's Health & Retirement Committee. He has also served
on numerous boards, including the Board of Trustees at Boston
Children's Hospital and on the Visiting Committee of the M.I.T.
Department of Economics. Loveman was an associate professor at the
Harvard University Graduate School of
Business Administration for nine years and he holds a Ph.D.
in economics from M.I.T.
Healthy.io is the global leader in
turning the smartphone camera into a clinical grade medical device.
By combining AI and machine learning for colorimetric analysis,
best-in-class UX design, and rigorous science, Healthy.io is
expanding access to health care. The company's first offering
— the only smartphone-powered urinalysis cleared by the FDA
and European regulators as equivalent to lab-based testing —
has been used by tens of thousands of patients using a range of
smartphones. By giving people the same test in any location without
a compromise in quality, Healthy.io is able to increase patient
compliance and satisfaction, improve health outcomes, close gaps in
care, and reduce total costs for payers and at-risk providers.
Healthy.io is partnering with health care and technology leaders
around the world including Siemens, Samsung, the UK National Health
Service, Geisinger Health, Johns Hopkins
University, and the US National Kidney Foundation. For more
information, visit www.Healthy.io or follow us on Twitter
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